Bezuclastinib: GIST FDA decision
Cogent states that its GIST NDA is under review with a November 30, 2026 target. Its September update explicitly separates this application from nonadvanced systemic mastocytosis on December 30 and advanced systemic mastocytosis on June 29, 2027.
Cogent Biosciences / COGTDrug catalystsRegulatory decisionTarget: 2026-11-30
What matters
Follow the exact application, indication and requested label. An FDA decision concerns the drug program, while the company’s stock also reflects its other assets and business.
- Same drug, three different regulatory applications and goal dates. A mastocytosis approval must not resolve a GIST market.
Primary evidence
FDA target 2026-11-30 — not a guaranteed decision date
Cogent · September update distinguishes all three applicationsPublished 2026-09-15
Potential outcome market
Will FDA approve bezuclastinib with sunitinib for the GIST application supported by PEAK by a separately fixed evidence cutoff?
This event is research, not a listed market. A market needs a precise question, resolution rules and liquidity before trading opens.